Kornimate/medical-research-clean huggingface dataset:
examine the psychosocial impacts of covid-19 pandemic.

Conditions: Psychosocial Impacts; COVID-19 Pandemic

Summary: this is an observational study examining the psychosocial impacts of the covid-19 pandemic in seven low-and-middle income countries (indonesia, iran, iraq, malaysia, pakistan, somaliland, and turkiye). the data was obtained on standardised measures of wellbeing (who well-being index), psychological distress (kessler 10), post-traumatic stress (ptsd checklist for dsm-5), post-traumatic growth (posttraumatic growth inventory), and a novel pandemic-related stress (covid psychosocial impacts scale). data was collected employing either a unilingual (in native language) or bilingual online survey (with english as a second language) from participants (n=2574) aged 18 and above using a non-probability convenient sampling. the findings enabled us to examine the psychosocial impacts of covid-19, validate the translations of the cpis and standardized measures; and determine the trajectory of study variables with pandemic exposure.


Eligibility criteria:
inclusion criteria: * aged 18 and above * currently residing in the country of interest. * additional inclusion criterion applies to bilingual studies; which is having english as a second language. exclusion criteria: * aged below 18 years. * not residing in the country of interest. * additional exclusion criterion applies to bilingual studies; which is not having english as a second language.

Keywords: psychological distress wellbeing mental health reliability and validity low and middle income countries cross-cultural comparisons
observational study of novomix® 50 for treatment of type 2 diabetics for 12 months

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to evaluate the blood glucose control when using novomix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. an additional objective is also to observe the different regimes of starting and maintaining the treatment with novomix® 50 during one year.


Eligibility criteria:
inclusion criteria: * type 2 diabetes treated with biphasic human insulin with or without metformin * inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with novomix® 50 exclusion criteria: * subjects with diagnosed type 1 diabetes mellitus * subjects treated with short acting or intermediate acting human insulin or any insulin analogue * subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits * subjects with a hypersensitivity to biphasic insulin aspart 50 (novomix® 50 )or to any of the excipients * women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months
vegf-targeted fluorescence near-infrared (nir) endoscopy in (pre)malignant esophageal lesions

Conditions: Esophageal Cancer; Dysplasia

Summary: to improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in barrett's esophagus (be), there is a need for better endoscopic visualization and the ability for targeted biopsies. optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. it is known that the biomarker vascular endothelial growth factor (vegf) is overexpressed in dysplastic and neoplastic areas in be segments versus normal tissue and has proven to be a valid target for molecular imaging. the university medical center groningen (umcg) developed a fluorescent tracer by labeling the vegf-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye irdye800cw. we hypothesize that when bevacizumab-irdye800cw is administered, it accumulates in vegf expressing high grade dysplasia (hgd) and esophageal adenocarcinoma (eac), enabling early cancer visualization using a newly developed fluorescent nir fiber-bundle. this hypothesis will be tested in this pilot intervention study.


Eligibility criteria:
inclusion criteria: * identified hgd or intramucosal eac (t1) and therefore candidate for endoscopic mucosal resection therapy * mentally competent person, 18 years or older. * written informed consent. * adequate potential for follow-up. exclusion criteria: * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * submucosal and invasive eac; eac with tumor-classification other than t1. * concurrent (uncontrolled) medical conditions which disqualify for an endoscopic mucosal resection procedure. * previously performed therapeutic endoscopic procedures. * pregnancy or breast feeding.

Keywords: eac hgd esophagus
bio-enhanced curcumin as an add-on treatment in mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: inflammatory bowel disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. as such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. several studies have proven that curcumin has well-established anti-inflammatory properties. however, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. the investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.


Eligibility criteria:
inclusion criteria: * patients who have mild to moderate ulcerative colitis, with a current partial mayo index greater than or equal to 2 and less than or equal to 6 * age 18 years and above * male or female * patients who have given consent and area able to follow the treatment given * patients who are able to record their responses in survey form at regular follow-up visits exclusion criteria: * patients who are in remission from ulcerative colitis, or who have a partial mayo index score of 0 or 1 * patients who have been taking azathioprine or mercaptopurine for \<12 weeks for the treatment of their ulcerative colitis * patients who are taking steroids or biologic agents for the treatment of their ulcerative colitis * patients who have severe ulcerative colitis, or who have a partial mayo index score of 7 or above * patients who are noncompliant with medication or regular follow up visits * patients who are unable to or unwilling to record their responses in survey form * patients with comorbid illnesses, including: diabetes mellitus, stage iii or above congestive heart failure, chronic pancreatitis, severe liver or renal disease * patients who have current gallstones or any biliary dysfunction * patients with anemia (hemoglobin \<10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities * patients who currently have an ongoing severe infection/sepsis * patients with a history of malignancy * patients who are currently pregnant or nursing * patients who are current smokers
sleep and pain in sickle cell disease

Conditions: Sickle Cell Disease; Sleep Disturbance; Pain

Summary: this is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.

the investigators propose to examine whether changes in sleep alter pain and pain-related outcomes in adults with sickle cell disease (scd). as many as 70% of adults with scd experience various sleep disturbances. pain and sleep are inter-related, such that pain disturbs sleep and disturbed sleep amplifies pain and increases risk for developing chronic pain. pain processing occurs in the central nervous system, where nociceptive input can be inhibited or facilitated and which can undergo both functional and structural plasticity. when plasticity results in amplification of pain, this central sensitization (cs) manifests as hyperalgesia, allodynia, and spreading of pain and is an important treatment target in its own right. a growing literature implicates central sensitization in scd, and the investigators find a strong association between laboratory-evoked cs and sleep disturbance in scd. the neural substrates involved in pain modulation are often disrupted in chronic pain, likely due to the demands pain places on cognitive resources, and similar effects are seen with chronic insomnia. it remains unclear whether these changes occur in scd and if improving sleep improves central modulation of pain. the potential for improved sleep to reduce pain and cs requires additional investigation, particularly given the significance of sleep disturbance as a mutable risk factor. the investigators will conduct a randomized trial in which it will be determined whether improvements in sleep reduce pain and alter brain processing of pain and cognitive stimuli. the aims are to determine whether treatment of sleep improves pain outcomes in scd and to determine whether treatment of sleep alters functional connectivity of cognitive and pain modulatory networks using brain imaging in scd.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell hemoglobinopathy (homozygous sickle cell disease, hemoglobin sc disease, or sickle/beta-thalassemia); * adequate facility with english; * stable dosing of medications (if taking) for pain and sleep; * reports symptoms of insomnia; * reports chronic pain exclusion criteria: * cognitive impairment; * unstable psychiatric disorder; * seizure disorder; * positive pregnancy or drug test
pilot study evaluating the use of simultaneous hbv, hcv, and hiv rapid tests

Conditions: HIV; Hepatitis B; Hepatitis C; Carcinoma, Hepatocellular; AIDS

Summary: this is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. the investigators will be testing for hepatitis b virus (hbv), hepatitis c virus (hcv), and human immunodeficiency virus (hiv). testing will be proposed to all persons seeking care at the centre d'accueil, de soins et d'orientation from the organization médecin du monde (caso, mdm). infection status of participants will be determined by either the standard test (elisa) or rapid test. the choice between tests will be determined randomly. the overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. in addition, results from these tests will allow the medical doctor to guide participants to appropriate care. all positive tests will be confirmed at a specialized hospital (hôptial saint-antoine, paris, france) and health-specific information will be obtained four months after testing.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * seeking care at the caso mdm health care center * accept to be followed at saint-antoine hospital in the event of a positive test. exclusion criteria: * currently under physician's care for viral hepatitis (hbv/hcv-specific) or hiv * already has been tested (must give any of the following as evidence): * results from hbv and hcv and hiv tests dating at least 3 months back * results from hcv and hiv tests dating at least 3 months back and hbv serology indicating that the participant is immunized against hbv.

Keywords: rapid test screening elisa hepatitis b virus hepatitis c virus human immunodeficiency virus access to care
early antibiotic therapy and vaccination

Conditions: Vaccination Reaction

Summary: neonatal sepsis is one of the most common causes of death in preterm infants. therefore, up to 80% of very low birth weight infants receive antibiotic therapy in their first week of life. antibiotic therapy is one of the most important influencing factors for the establishment of the intestinal microbiome, which in turn modulates neonatal immune development. in this pilot study, it will be investigated, if antibiotic therapy in the first week of life influences the vaccination response of preterm infants.

the aim of the study is to compare antibody titers against hepatitis b, polio, pertussis, haemophilus influenza b, tetanus, diphteria and pneumococcus in very low birth weight infants (vlbwi) infants who received antibiotic therapy in their first week of life and who did not. in this pilot study, 20 vlbwi infants will be included (10 per group). infants will be matched fo age and gender.

Eligibility criteria:
inclusion criteria: * born at university hospital tübingen * at least one dose of antibiotics within the first week of life exclusion criteria: * genetic disorders * chronic infections * hematological disorders * immunoglobulins within the first 60 days of life * immunological disorders * infants from hepatitis b positive mothers
a study of mk-1084 with midazolam and digoxin in healthy participants (mk-1084-009)

Conditions: Non-small Cell Lung Cancer

Summary: the goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or pk study). researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called mk-1084. researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without mk-1084.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * is medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vitals signs, and electrocardiograms (ecgs) * has a body mass index (bmi) ≥18 and ≤32 kg/m\^2, inclusive exclusion criteria: the key exclusion criteria include but are not limited to the following: * has a medical history that may confound the results of the study or poses an additional risk to the participant in the study * has a history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds
safety, tolerability, pharmacodynamics and pharmacokinetics of inhaled tpi 1100 in healthy volunteers

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will look at the safety and tolerability of tpi 1100 in healthy volunteers and look at pharmacodynamic (pd) effect on mrna expression of pde 4b/d \& 7a in blood and in sputum.

study was not initiated and terminated before start-up.

Eligibility criteria:
inclusion criteria: * healthy, male or female volunteers aged 18 to 55 years inclusive * screening/baseline fev1 greater than 90% predicted, * body mass index (bmi) of 19 to 28 inclusive, * clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the investigator exclusion criteria: * airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems, * breast-feeding or pregnancy, * positive tests for smoking tobacco, alcohol, hepatitis b-surface antigen, hepatitis c antibody, and hiv at screening, * history of serious adverse reaction to any drugs,

Keywords: copd
outcomes of a multidisciplinary program for the treatment of chronic pelvic pain

Conditions: Chronic Pelvic Pain Syndrome

Summary: the goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. the main questions it aims to answer are: * how does the handbook and follow-up impact patient satisfaction? * how does the handbook and follow-up impact patient pain and quality of life scores? participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule.

chronic pelvic pain (cpp) is a common and multi-factorial condition resulting in high physical, emotional and psychological burden for patients. multimodal treatments have been shown to be most effective in addressing the multifactorial nature of cpp, but remain challenging for patients and providers to navigate. investigators have created a cpp treatment guide which clearly defines resources and management strategies in an effort to help patients understand their own diagnosis, treatment options and follow up schedule. the treatment guide includes mobile and web-based resources and applications specifically chosen to empower patients with information and to promote self-efficacy. the treatment guide is designed to be easily understood, visually appealing, and largely translatable from institution to institution. patients using the treatment guide will be followed with a clearly defined follow up schedule, which includes touch points between appointments to aid with resource navigation. the investigators hypothesize that patients with cpp who are provided our treatment guide will experience improved satisfaction with their care, in addition to improved quality of life measures and pain scores as compared to those who undergo standard treatment.

Eligibility criteria:
inclusion criteria: * women age 18 or older * diagnosis of chronic pelvic pain exclusion criteria: * primary language other than english * pregnancy * inability to attend follow-up appointment

Keywords: treatment guide patient satisfaction pain scores
vagal nerve stimulation: safeguarding heart failure patients

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of the vanguard study is to demonstrate the safety of vagal nerve stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.


Eligibility criteria:
inclusion criteria: 1. left ventricular dysfunction of ischemic or idiopathic dilated cardiomyopathy etiology, characterized by lvef \< 40% 2. chronic heart failure with symptoms characterized by nyha functional class ii or iii at the time of enrollment despite optimal drug regimen 3. optimal drug regimen as defined in the current european guidelines 4. sinus rhythm, with spontaneous heart rate ≥ 60bpm at the time of enrollment 5. signed and dated informed consent main exclusion criteria: * patient implanted with or eligible to cardiac pacing as per current guideline * risk for neck surgery in the electrode zone within a year after enrollment * patient with right carotid artery stenosis * symptomatic hypotension * history of peptic ulcer disease or upper gastrointestinal bleeding * asthma, severe copd, or severe restrictive lung disease * advanced diabetes mellitus * recent acute myocardial infarction, coronary artery surgery or revascularization (or already planned) * recent cerebro-vascular event * significant valvulopathy * advanced renal failure * previous heart transplant or current lvad device therapy * life expectancy \< 1 year for non-cardiac cause * patient included in another clinical study that could confound the results of this study * inability to understand the purpose of the study or to perform the procedures of the study * unavailability for scheduled follow-up * age of less than 18 years or under guardianship * pregnancy
effect of formula on growth of infants from overweight or obese mothers

Conditions: Infant Nutrition

Summary: the purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth


Eligibility criteria:
inclusion criteria: * healthy newborn infant * birth weight between 2500g and 4800g * singleton birth * mother's bmi before pregnancy was between 26 and 25 * for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age * for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age * having obtained signed informed consent of legal representative exclusion criteria: * body weight smaller than 5th percentile for that gestational age * newborn whose mother has diabetes * newborn whose mother has a drug dependence during pregnancy * newborn currently participating in another trial

Keywords: infant formula obesity growth
sensing physiological symptoms of opioid withdrawal and cravings in patients with opioid use disorder

Conditions: Opioid Withdrawal; Opioid Use Disorder

Summary: the primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

this is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. the embraceplus smartwatch and corti sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.

Eligibility criteria:
inclusion criteria 1. participant shows signs of current opioid dependence; prescription or non-prescription 2. participant is seeking an induction to medications for opioid use disorder (moud) 3. participant is between 18 and 50 years of age 4. participant is english proficient 5. participant is able to provide informed consent and function at an intellectual level sufficient for study requirements 6. participant is willing to wear wearable sensors for 14 days exclusion criteria 1. participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition 2. participant has a history of epileptic seizures 3. participant has a history of neurological diseases or traumatic brain injury 4. participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation 5. subject has significant current suicidal ideation within 30 days prior to screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the columbia-suicide severity rating scale (c-ssrs) completed at screening, that, in the opinion of the investigator, warrants exclusion from the trial 6. females who are pregnant or lactating 7. participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Keywords: physiological signals opioid detoxification cravings autonomic nervous system